Patient-specific elbow guides and associated methods

ABSTRACT

A patient-specific alignment guide includes a three-dimensional engagement surface customized in a pre-operating planning stage by computer imaging to closely mate and conform to a corresponding bone portion of a patient&#39;s elbow joint. The patient-specific alignment guide defines a first longitudinal guiding bore aligned with a reference axis associated with the elbow joint of patient when the alignment guide is mounted onto the corresponding bone portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/744,022 filed on Jan. 17, 2013, which is a divisional of U.S.application Ser. No. 12/888,005 filed on Sep. 22, 2010, now U.S. Pat.No. 8,377,066 issued on Feb. 19, 2013, which is a continuation-in-partof U.S. application Ser. No. 12/714,023 filed Feb. 26, 2010, now U.S.Pat. No. 8,241,293 issued Aug. 14, 2012, which is a continuation-in-partof U.S. application Ser. No. 12/571,969 filed on Oct. 1, 2009, which isa continuation-in-part of U.S. application Ser. No. 12/389,901 filed onFeb. 20, 2009, now U.S. Pat. No. 8,133,234 issued Mar. 13, 2012, whichis a continuation-in-part of U.S. application Ser. No. 12/211,407 filedon Sep. 16, 2008, now U.S. Pat. No. 8,608,748 issued on Dec. 17, 2013,which is a continuation-in-part of U.S. application Ser. No. 12/039,849filed on Feb. 29, 2008, now U.S. Pat. No. 8,282,646 issued Oct. 9, 2012,which: (1) claims the benefit of U.S. Provisional Application No.60/953,620 filed on Aug. 2, 2007, U.S. Provisional Application No.60/947,813 filed on Jul. 3, 2007, U.S. Provisional Application No.60/911,297 filed on Apr. 12, 2007, and U.S. Provisional Application No.60/892,349 filed on Mar. 1, 2007; (2) is a continuation-in-part U.S.application Ser. No. 11/756,057 filed on May 31, 2007, now U.S. Pat. No.8,092,465 issued Jan. 10, 2012, which claims the benefit of U.S.Provisional Application No. 60/812,694 filed on Jun. 9, 2006; (3) is acontinuation-in-part of U.S. application Ser. No. 11/971,390 filed onJan. 9, 2008, now U.S. Pat. No. 8,070,752 issued Dec. 6, 2011, which isa continuation-in-part of U.S. application Ser. No. 11/363,548 filed onFeb. 27, 2006, now U.S. Pat. No. 7,780,672 issued Aug. 24, 2010; and (4)is a continuation-in-part of U.S. application Ser. No. 12/025,414 filedon Feb. 4, 2008, now U.S. Pat. No. 8,298,237 issued Oct. 30, 2012, whichclaims the benefit of U.S. Provisional Application No. 60/953,637 filedon Aug. 2, 2007.

This application is a continuation of U.S. application Ser. No.13/744,022 filed on Jan. 17, 2013, which is also a continuation-in-partof U.S. application Ser. No. 12/483,807 filed on Jun. 12, 2009, now U.S.Pat. No. 8,473,305 issued on Jun. 25, 2013, which is acontinuation-in-part of U.S. application Ser. No. 12/371,096 filed onFeb. 13, 2009, which is a continuation-in-part of U.S. application Ser.No. 12/103,824 filed on Apr. 16, 2008, now abandoned, which claims thebenefit of U.S. Provisional Application No. 60/912,178 filed on Apr. 17,2007.

This application is a continuation of U.S. application Ser. No.13/744,022 filed on Jan. 17, 2013, which is also a continuation-in-partof U.S. application Ser. No. 12/872,663 filed on Aug. 31, 2010, now U.S.Pat. No. 8,407,067 issued on Mar. 26, 2013, which claims the benefit ofU.S. Provisional Application No. 61/310,752 filed on Mar. 5, 2010.

The disclosures of the above applications are incorporated herein byreference.

INTRODUCTION

Various patient specific templates and other guides are used for kneearthroplasty. The present teachings provide various patient-specificalignment guides, cutting guides and other instruments for the elbowjoint.

SUMMARY

The present teachings provide a patient-specific alignment guide thatincludes a three-dimensional engagement surface customized in apre-operating planning stage by computer imaging to closely mate andconform to a corresponding bone portion of a patient's elbow joint.

In one embodiment, the patient-specific-alignment guide defines a firstlongitudinal guiding bore aligned with a reference axis associated withthe elbow joint of patient when the alignment guide is mounted onto thecorresponding bone portion.

In another embodiment, the patient-specific-alignment guide defines aguiding bore for guiding a pin along a reference axis and a guidingsurface for guiding a blade for a bone-cut along a patient-specificresection plane, wherein the guiding bore and guiding surface arecustomized for the patient during a preoperative planning stage.

The present teachings provide a method of preparing an elbow joint foran implant. In one embodiment, the method includes mounting apatient-specific alignment guide including a three-dimensionalengagement surface custom-made by computer imaging to a correspondingclosely conforming bone portion of a patient's elbow joint, andinserting into the bone portion a first pin along an anatomic axis ofthe elbow joint through a first longitudinal guiding bore of thepatient-specific alignment guide. The method also includes insertinginto the bone portion a second pin through a second longitudinal guidingbore of the patient-specific alignment guide, and removing thepatient-specific alignment guide without removing the first and secondpins. The method further includes slidably mounting a first resectionguide over the first and second pins, and resecting the bone portion forreceiving an implant.

In another embodiment, the method includes mounting a patient-specificalignment guide including a three-dimensional engagement surfacecustom-made by computer imaging to a corresponding closely conformingbone portion of a patient's elbow joint. The method also includesinserting into the bone portion a first pin along an anatomic axis ofthe elbow joint through a first longitudinal guiding bore of thepatient-specific alignment guide, and resecting the bone portion along afirst plane through a first longitudinal slot of the patient-specificalignment guide for receiving an implant.

The present teachings provide a medical device for an elbow jointincluding a cutting component and a guiding component. The cuttingcomponent includes a planar engagement surface for engaging orcontacting a planar resected surface of a bone, a first elongated slotalong a first plane perpendicular to the engagement surface for guidinga first planar resection and a second elongated slot along a secondplane at an oblique angle relative the first plane for guiding a secondplanar resection at an oblique angle relative to the first planarresection. The cutting component also includes an aperture. The guidingcomponent includes first and second longitudinal bores aligned alongfirst and second reference axes for receiving first and second alignmentpins engageable with the bone. The guiding component includes anextension slidably received through the aperture of the cuttingcomponent for orienting the first and second planes of the cuttingcomponent in pre-planned orientations relative to the first and secondreference axes.

Further areas of applicability of the present teachings will becomeapparent from the description provided hereinafter. It should beunderstood that the description and specific examples are intended forpurposes of illustration only and are not intended to limit the scope ofthe present teachings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present teachings will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1A is an anterior view illustrating the bones of a right elbow;

FIG. 1B is a posterior view illustrating the bones of a right elbow;

FIG. 2A is a perspective view of the Discovery® Elbow System for totalelbow joint replacement commercially available from Biomet Orthopedics,Inc., Warsaw, Ind., USA;

FIG. 2B is a perspective view of a Lateral Resurfacing Elbow (LRE™)system commercially available from Biomet UK, Ltd, Bridgend, SouthWales, UK;

FIG. 3 is an environmental perspective view of a patient-specificalignment guide illustrated for the distal humerus according to thepresent teachings;

FIG. 4A is an environmental perspective view of a patient-specific guideillustrated for the distal humerus according to the present teachings;

FIG. 4B is a sectional of the patient-specific guide of FIG. 4A takenalong line 4B-4B;

FIG. 4C is an environmental sectional view of an implant fitted to aresected elbow joint;

FIG. 5 is an environmental perspective view of a patient-specificalignment guide illustrated for the distal humerus according to thepresent teachings;

FIG. 6 an environmental sectional view of placement of first and secondpins in locations determined by a patient-specific guide according tothe present teachings;

FIGS. 7A and 7B are environmental perspective views illustrating acutting guide supported on first and second lateral pins for performinga distal cut according to the present teachings;

FIG. 7C is a detail of a modular posterior cutting guide for performinga distal cut according to the present teachings;

FIG. 7D is a detail of a modular posterior cutting guide for performinga distal cut according to the present teachings;

FIGS. 8A and 8B are environmental perspective views illustrating acutting guide supported on first and second lateral pins for performingan anterior cut and an angled posterior cut according to the presentteachings;

FIG. 8C is an environmental sectional view illustrating a cutting guidesupported on a distal resected surface and mounted on first and secondlateral pins for performing an anterior cut and an angled posterior cutand the corresponding anterior and angled posterior cuts according tothe present teachings;

FIG. 9 is an environmental sectional view illustrating a cutting guidesupported on distal resected surface and mounted on first and secondlateral pins for performing an anterior cut and an angled posterior cutafter according to the present teachings;

FIG. 10 is an environmental perspective view of a patient-specificalignment guide with first and second posterior pins illustrated for thedistal humerus according to the present teachings;

FIG. 11 is an environmental perspective view of a cutting guidesupported on first and second posterior pins for performing a distal cutaccording to the present teachings;

FIG. 12 is an environmental perspective view of a cutting guidesupported on first and second posterior pins for performing an anteriorcut and an angled posterior cut according to the present teachings;

FIG. 13 is an environmental sectional view of a patient-specific guideillustrated for the ulna of an elbow joint according to the presentteachings;

FIG. 14A is an environmental sectional view of a patient-specificalignment guide illustrated for the olecranon fossa of the distalhumerus of an elbow joint according to the present teachings;

FIG. 14B is an environmental perspective view of a patient-specificcutting guide illustrated for the olecranon fossa of the distal humerusaccording to the present teachings; and

FIG. 15 is an environmental sectional view of a patient-specific guideillustrated for the capitellum of the distal humerus according to thepresent teachings.

DESCRIPTION OF VARIOUS ASPECTS

The present teachings generally provide patient-specific surgicalinstruments that include, for example, alignment guides, drill guides,templates, cutting/resection guides for use in elbow joint replacement,elbow resurfacing procedures and other procedures related to the elbowjoint or the various bones of the elbow joint. The patient-specificinstruments can be used either with conventional implant components orwith patient-specific implant components prepared with computer-assistedimage methods. Computer modeling for obtaining three dimensional imagesof the patient's anatomy using MRI or CT scans of the patient's anatomy,the patient specific prosthesis components, and the patient-specificguides, templates and other instruments can be provided by various CADprograms and/or software available, for example, by Materialise USA, AnnArbor, Mich.

The patient-specific instruments and associated patient-specificimplants disclosed herein can be generally formed using computermodeling based on the patient's 3-D anatomic image generated from imagescans. The patient-specific instruments can have a three-dimensionalengagement surface that is made to conformingly contact and match athree-dimensional image of the patient's bone surface (imagedselectively with associated soft tissues or without soft tissue, i.e. anactual bone surface), by the computer methods discussed above. Thepatient-specific instruments can include custom-made guiding formations,such as, for example, guiding bores or cannulated guiding posts orcannulated guiding extensions or receptacles that can be used forsupporting or guiding other instruments, such as drill guides, reamers,cutters, cutting guides and cutting blocks or for inserting pins orother fasteners according to a surgeon-approved pre-operative plan.

In various embodiments, the patient-specific instruments can alsoinclude one or more patient-specific cutting guides for receiving andguiding a cutting blade at corresponding patient-specific resectionorientations relative to a selected anatomic axis for the specificpatient. The patient-specific instruments can also include guidingformations for guiding the implantation of patient-specific oroff-the-shelf implants associated with the surgical procedure, such ashumeral and ulnar implant components. The geometry, shape andorientation of the various features of the patient-specific instruments,as well as various patient-specific implants, if used, can be determinedduring the pre-operative planning stage of the procedure in connectionwith the computer-assisted modeling of the patient's anatomy. During thepre-operative planning stage, patient-specific instruments, custom,semi-custom or non custom implants and other non custom tools, can beselected and the patient-specific components can be manufactured for aspecific-patient with input from a surgeon or other professionalassociated with the surgical procedure, as described in the commonlyassigned and co-pending patent applications listed in the crossreference section and incorporated herein by reference.

In the following discussion, the terms “patient-specific”, “custom-made”or “customized” are defined to apply to components, including tools,implants, portions or combinations thereof, which include certaingeometric features, including surfaces, curves, or other lines, andwhich are made to closely conform as mirror-images or negatives ofcorresponding geometric features of a patient's anatomy obtained orgathered during a pre-operative planning stage based on 3-D computerimages of the corresponding anatomy reconstructed from image scans ofthe patient by computer imaging methods. Further, patient specificguiding features, such as, guiding apertures, guiding slots, guidingmembers or other holes or openings that are included in alignmentguides, drill guides, cutting guides, rasps or other instruments or inimplants are defined as features that are made to have positions,orientations, dimensions, shapes and/or define cutting planes and axesspecific to the particular patient's anatomy including various anatomicor mechanical axes based on the computer-assisted pre-operative planassociated with the patient.

Referring to FIGS. 1A and 1B, anterior and posterior views of an elbowjoint 70 are illustrated to highlight areas on which thepatient-specific guides of the present teachings are adapted to conformto. The elbow joint 70, including subchondral bone with or withoutcartilage or other soft tissue depending on surgeonrequirements/recommendation of a particular patient, is modeledpreoperatively as three-dimensional computer image from a series ofscans of the elbow joint 70 of a particular patient. As illustratedschematically for simplicity and without showing any soft tissue forfurther reference below, the elbow joint 70 includes the bone portionsof the distal humerus 72, the proximal radius 74 and the proximal ulna76. In the anterior view of FIG. 1A, the capitellum (capitulum humeri)is illustrated at 78, the trochlea at 80, and the lateral and medialepicondyles at 82, 84 respectively. In the posterior view of FIG. 1B,the olecranon fossa of the distal humerus 72 is illustrated at 86 andthe olecranon of the proximal ulna is illustrated at 88.

Referring to FIGS. 2A and 2B, exemplary implants 100 a, 100 b for theelbow joint are illustrated. FIG. 2A illustrates an exemplary totalelbow arthroplasty implant 100 a, commercially available from BiometOrthopedics, Inc., Warsaw, Ind., USA, as Discovery® Elbow System. Theelbow arthroplasty implant 100 a includes a spherical hinge 102 couplinga humeral component 104 and an ulnar component 106. The humeralcomponent 104 includes a bowed stem 108, a cylindrical base 110 and ananti-rotation flange 112. The ulnar component 106 includes a stem 114forming an anatomic anterior neck angle and a polyethylene insert 116.

FIG. 2B illustrates an exemplary elbow resurfacing implant 100 bcommercially available from Biomet UK, Ltd, Bridgend, South Wales, UK,as Lateral Resurfacing Elbow (LRE™) system. This implant 100 b ismodular and includes a radial head component 120 and a capitellarcomponent 122 with optional implantation of one or both components.Details of the implantation techniques and surgical procedures for theimplants are available in the manufacturers' websites.

Referring to FIG. 3, a patient-specific alignment guide 200 isillustrated. The patient-specific alignment guide 200 can be specific toportions of the lateral epicondyle 82 and/or capitellum 78 of the distalhumerus 72 of the patient and includes a three-dimensional engagementsurface 202, custom-made by computer imaging to conform to acorresponding portion of a patient's corresponding anatomy, such an areaof the epicondyle or capitellum or other area of the distal humerus 72.The alignment guide 200 can include a patient-specific guiding feature204, which can be computer modeled to be aligned with a reference axis,including an axis of rotation A of the elbow joint 70 of the patient.The guiding feature 204 can be a tubular or partially tubular structurewith an elongated guiding bore 206 at a patient-specific orientation andlocation for guiding a drill bit, a pin, or other tool to make a holethrough the distal humerus 72 at the reference axis A. Aguiding/alignment pin 220, such as a Steinmann pin, can be inserted intothe distal humerus 72 through the guiding bore 206 when the alignmentguide 200 is mounted on the distal humerus 72. It should be noted thatbecause of the patient-specific nature of the engagement surface 202,the alignment guide 200 can fit in a unique position/orientation overthe capitellum 78. In some embodiments, the alignment guide 200 canautomatically align the guiding bore 206 along the reference axis A,which can also be an axis of rotation of the patient's elbow joint orany other axis.

Referring to FIGS. 4A and 4B, a patient-specific combined alignment andresection/cutting guide 300 for the distal humerus is illustrated. Thecombined guide 300 includes a three-dimensional patient-specificengagement surface 302, a tubular guiding feature 304 with an internalguiding bore 306 at a patient-specific orientation and location for apin and a plurality of elongated guiding slots 308 for guiding a bladeto perform the cuts required for inserting an elbow implant. In someembodiments, the guiding bore 306 can reference a selected anatomic axisof the joint or any other axis. Three exemplary guiding slots 308 fordistal, anterior and posterior humeral cuts are shown. It should benoted that any number of desired guiding slots 308 may be included inthe guide 300. An exemplary humeral implant 350, having inner surfaces352 corresponding to distal, anterior and posterior humeral cuts, isshown in FIG. 4C.

Referring to FIGS. 5 and 6, a patient-specific alignment guide 400 forthe lateral surface 77 of the distal humerus 72 is illustrated. Thealignment guide 400 includes a three-dimensional patient-specificengagement surface 402 for the lateral surface 77 of the distal humerus72, optionally including portions of the lateral epicondyle or thecapitellum or other anatomic landmarks of the lateral surface 77. Thealignment guide 400 can also include a first guiding feature 404 a witha first internal guiding bore 406 a at a patient-specific orientationand location for a first alignment pin 220 a. As discussed above, insome embodiments the guiding bore 406 a can reference an anatomic axis(or first axis) A, such as an epicondylar axis or a rotation axis of theelbow joint of the specific patient, or any other selected axis. Thealignment guide 400 can include a second guiding feature 404 b with asecond internal guiding bore 406 b for a second alignment pin 220 breferencing a second axis B parallel to the first axis A. The secondalignment pin 220 b can be provided for additional rotational stabilityand for supporting various resection instruments, as discussed below.The corresponding first and second alignment pins 220 a, 220 b extendfrom the lateral surface 77 toward the medial surface 79 of the distalhumerus 72 and can be used for guiding osteotomy instruments or otherinstruments along patient specific orientations and locations of theaxes A and B, as discussed below. The first and second guiding features404 a, 404 b can be formed as a single integral (monolithic) structureas shown in FIG. 5, or as two separate elongated structures extendingfrom the alignment guide 400.

After the first and second alignment pins 220 a, 220 b are fixed on thelateral surface 77 of the distal humerus 72, the alignment guide 400 isslid off the first and second alignment pins 220 a, 220 b and removed,while the first and second alignment pins 220 a, 220 b remain attachedto the distal humerus, as illustrated in FIG. 6. Alternatively, firstand second holes 90 a, 90 b can be drilled or marked through the firstand second guiding bores 406 a, 406 b for the first and second alignmentpins 220 a, 220 b, the alignment guide 400 removed, and then the firstand second alignment pins 220 a, 220 b inserted through the pre-drilledor pre-marked holes 90 a, 90 b.

Referring to FIGS. 7A and 7B, a posterior resection or cutting guide 500can be mounted on and aligned by the first and second alignment pins 220a, 220 b for performing a distal cut of the distal humerus from aposterior to an anterior surface of the distal humerus. The posteriorcutting guide 500 can include a cutting component 502 oriented to abutagainst the posterior surface of the distal humerus and a guidingcomponent 530 oriented for lateral placement relative to the distalhumerus and slidably mounted over the first and second alignment pins220 a, 220 b, as illustrated in FIG. 7A. The lateral-medial orientationis illustrated with an arrow LM and the posterior-anterior orientationis illustrated with arrow PA in FIG. 7A. The cutting and guidingcomponents 502, 530 can be modularly or integrally connected via aconnector 520, as discussed below.

The cutting component 502 can be in the form of a cutting block havingopposite first and second (front and back/engagement) surfaces 520 a,510 b, opposite side surfaces (distal and proximal) 510 c, 510 d, andopposite end surfaces (lateral and medial) 510 e, 510 f. The cuttingcomponent 502 can include one or more elongated slots 504 extendingalong the lateral-medial orientation for receiving a saw blade. Theelongated slots 504 are automatically aligned along patient-specificpositions determined during the preoperative planning stage for thepatient when the posterior cutting guide 500 is mounted over the firstand second alignment pins 220 a, 220 b. The cutting component 502 canalso include a window elongated in the lateral-medial direction. Thecutting component 502 can include a plurality of holes 506 that can bearranged in clusters for locking the cutting guide 500 with pins ontothe distal humerus during the cutting operation.

The guiding component 530 can include a body 531 having first and secondlongitudinal guiding bores 532 a, 532 b slidably mounted over the firstand second alignment pins 220 a, 220 b to orient the cutting component502 in a patient-specific orientation and position for performing thedistal cut as determined in the preoperative planning stage. Althoughthe body 531 of the guiding component 530 can have any shape, such as acylindrical or prismatic bar, some shapes allow the posterior cuttingguide 500 to be used in both the right and left humerus withoutincreasing the bulk or size of the components. An exemplary shape of thebody 531 for right and left humerus is illustrated in FIG. 7A andincludes first and second portions 534 a, 543 b coupled at an angle βdefining a body 501 with an arrow-shaped cross-section. The firstguiding bore 532 a for the anatomic axis A is positioned at the junctureof the first and second portions 534 a, 534 b (apex of the angle β). Thesecond guiding bore 534 b is defined through the second portion 534 band a third guiding bore 532 c is defined through the first portion 534a symmetrically to the second guiding bore 532 b. The first and secondguiding bores 532 a, 532 b can, thus, be used for the left humerus,while the first and third guiding bore 532 a, 532 c can be used for theright humerus in connection with the cutting component 502 which issymmetric about a medial-lateral axis, as illustrated in FIG. 2A.

As discussed above, the connector 520 can be integrally attached to thecutting and guiding components 502, 530, as illustrated in FIG. 7A. Theconnector 520 can be a polygonal bar for providing a clearance betweenthe cutting and guiding components 502, 530. For example, the connector520 can be L-shaped with a first end portion 520 a coupled to cuttingcomponent 502 and a second end portion 520 b coupled to the guidingcomponent 530. Intermediate portions may be included for certainattachment configurations. The first end portion 520 a can be attachedto any of the surfaces 510 e, 510 c, 510 d.

The connector 520 can also be removably coupled to the cutting component502, as illustrated in FIGS. 7C and 7D. In one exemplary embodiment, thefirst end portion 520 a of the connector can be removably coupled to oneof the side or end surfaces 510 e, 510 f, 510 c, 510 d of the cuttingcomponent with T-slot or dovetail or rectangular slot or other quickconnect/disconnect connection. FIG. 7C illustrates a T-slot connectionat the lateral end surface 510 e of the cutting component 502. A splitT-shaped extension 522 of the first end portion 520 a can be slidablyreceived in a corresponding T-shaped slot 512 defined on lateral endsurface 510 e of the cutting component 502. A locking or set screw canbe threaded through a bore 524 of the first end portion 520 a andthrough the split T-extension 522 to lock the connection. The lockingscrew 526 can include an enlarged head 528 received in a correspondingrecess 527 of the connector 520. Similarly, FIG. 7D illustrates arectangular slot 511 slidably receiving a corresponding rectangular end521 of the first portion 520 a. A locking screw can be threaded througha bore first end portion 520 a and into a corresponding threaded hole513 at the base of the rectangular slot 511. It will be appreciated thatother slidable, snap or quick connect with locking options can be usedto removably interconnect and lock the cutting component 502 and theguiding component 530 therebetween. The distal cut is performed with thecutting guide 500 assembled on the distal humerus.

Referring to FIGS. 8A-8C and 9, after a distal cut is made using theposterior cutting guide 500, the posterior cutting guide 500 can be slidoff or otherwise removed from the first and second alignment pins 220 a,220 b. A distal cutting guide 600 (FIGS. 8A-8C) or 600 a, FIG. 9) can bemounted over the first and second alignment pins 220 a, 220 b on thedistal resected surface 92 of the distal humerus 72. The distal cuttingguide 600 can be made as an integral (monolithic) unit or can be modularincluding a cutting component 602 and a guiding component 630, asillustrated in FIGS. 8A-8C. The guiding component 630 can include firstand second guiding bores 632 a, 632 b for slidably receiving the firstand second alignment pins 220 a, 220 b. The guiding component 630 canalso include an extension 634 for removably supporting the cuttingcomponent 602. The extension 634 can be oriented along a third axis Cthat is substantially perpendicular to the direction of the first andsecond parallel axes A and B of the alignment pins 220 a, 220 b. Thedistal cutting guide 600 a of FIG. 9 includes a set screw 640 forlocking the cutting component 602 to the guiding component 630.

The cutting component 602 can be shaped as a cutting block and include afirst surface or bone engagement surface 604 and an opposite or secondsurface 606. The bone engagement surface 604 is substantially planar orflat for positioning the cutting component 602 on the distal resectedsurface 92 of the distal humerus 72. The cutting component 602 caninclude a first elongated planar slot 608 oriented perpendicularly to orat any desired angle relative to the bone engagement surface 604 and asecond elongated planar slot 610 at an oblique angle relative to thebone engagement surface 604 for guiding, respectively, a posteriorangled cut 94 and an anterior cut 96. As illustrated in FIG. 8C, thefirst elongated planar slot 608 and the corresponding posterior angledcut 94 are oriented at an oblique angle γ relative to the third axis C.The angle γ is an acute angle, as illustrated in FIG. 8C. The secondelongated planar slot 610 and the corresponding anterior cut 96 areoriented parallel to the third axis C and perpendicular to the first andsecond surfaces 604, 606. The cutting component 602 can include anopening 612 slidably receiving the extension 634 for coupling thecutting component 602 to the guiding component 630 and orienting thefirst and second elongated slots 608, 610 and the correspondingposterior angled cut 94 and anterior cut 96 in pre-planned orientationsand positions relative to the first axis A, which is an anatomic axisfor the elbow joint, as discussed above. The opening 612 and thecross-section of the extension 634 can be mating and keyed or havemating non-rotatable shapes, e.g., rectangular, oval or polygonal. Inother embodiments, the opening 612 can have a circular or otherrotatable shape. The cutting component 602 can also include a pluralityof holes 614 for securing the cutting component 602 to the bone duringresection.

In the procedures described above in connection with FIGS. 5-9, thefirst and second alignment pins 220 a, 220 b were placed through thelateral surface of the distal humerus 72 extending from the lateraltoward the medial direction. It is also possible to place the first andsecond alignment pins 220 a, 220 b posteriorly, i.e., from the posteriortoward the anterior surface of the distal humerus 72, as illustrated inFIGS. 10-12. It will be appreciated that the selected axes A′ and B′ aredifferent anatomic or reference axes than the first and second axes Aand B and are oriented in the posterior-anterior direction. The axes A′and B′ can be perpendicular to or at any other oblique angle relative tothe rotation axis of the elbow joint. As described above, apatient-specific alignment guide 700 can assist in the placement of thefirst and second alignment pins 220 a, 220 b. The patient-specificalignment guide 700 includes a three-dimensional patient-specificengagement surface 702 for the posterior surface of the distal humerus72, and a first and second guiding bores 704 a, 704 b designed during apreoperative planning stage and based on the patient's anatomy fororienting the first and second alignment pins 220 a, 220 b alongpredetermined directions of axes A′ and B′. The patient-specificalignment guide 700 can also include a removable or permanently attachedhandle 710. Similar handles can be used with the other patient-specificalignment guides described herein.

Referring to FIG. 11, after the patient-specific alignment guide 700 isremoved, a posterior resection/cutting guide 750 can be removablymounted over the first and second alignment pins 220 a, 220 b throughcorresponding apertures 752 a, 752 b. The posterior cutting guide 700can include an elongating slot 754 for guiding the distal cut of thedistal humerus 72. In another embodiment, the posterior cutting guide750 can be combined with the patient-specific alignment guide 700,either integrally or by a modular connection (dovetail, T-slot, etc.).In this regard, the combined cutting/alignment guide 700/750 can thenengage the posterior surface of the distal humerus 72 with an engagementsurface 758 which is patient-specific.

Referring to FIG. 12, after the distal cut is made, the posteriorcutting guide 750 is removed and a distal cutting guide 800 is mountedon the resected distal surface of the distal humerus. Similarly to thedistal cutting guide 600 discussed above in connection with FIGS. 8A-8C,the distal cutting guide 800 can include a cutting component 802 and aguiding component 830 with first and second bores 832 a, 832 b forslidably receiving the first and second alignment pins 220 a, 220 b. Thecutting component 802 can include a first elongated planar slot 808oriented obliquely relative to the reference axes A′, B;′ and a secondelongated planar slot 810 oriented perpendicularly relative to thereference axes A′, B;′ for guiding, respectively, a posterior angled cut94 and an anterior cut 96 (see FIG. 8C for exemplary cuts 94, 96). Thecutting component 802 can include an opening 812 slidably receiving anextension 834 of the guiding component 830 and orienting the first andsecond elongated slots 808, 810 and the corresponding posterior angledcut 94 and anterior cut 96 in pre-planned orientations and positionsrelative to the reference axes A′, B′. The opening 812 can be elongatedto allow adjustment in the direction of the reference axes A′ and B′ andcan be secured, after adjustment, with a blocking stop inserted in theopening 812 or with pins through the holes 814. It will be appreciatedthat a complete posterior angled cut 94 can be obstructed by the guidingcomponent 830 in this configuration. Accordingly, after the posteriorangled cut is initiated or partially resected, the entire cutting guide800 and the first and second alignment pins 220 a, 220 b can be removedand the posterior angled cut 94 finished with a saw blade.Alternatively, the guiding component 830 the first and second alignmentpins 220 a, 220 b can be removed while the cutting component 802 remainssecured on the bone with pins through the holes 814 in its originalmounted position defined by the first and second alignment pins 220 a,220 b.

Referring to FIG. 13, a patient-specific alignment guide 850 isillustrated. The patient-specific alignment guide 850 is specific to theolecranon 88 of proximal ulna 76 of the patient and includes athree-dimensional engagement surface 852, custom-made by computerimaging to conform and nest to a corresponding portion of a patient'solecranon 88. The alignment guide 850 can include a guiding feature 854,computer modeled to be aligned with an anatomic axis A″ of the elbowjoint 70 of the patient. The guiding feature 854 can be a tubular orpartially tubular structure with an elongated guiding bore 856 forguiding an alignment pin 220 into the proximal ulna 76 when thealignment guide 850 is mounted on the olecranon 88. Because of thepatient-specific nature of the engagement surface 852, the alignmentguide 850 can fit in a unique position/orientation over the olecranon 88and automatically align the guiding bore 856 along the anatomic axis A″.The alignment pin 220 can be used to reference the anatomic axis A″ foradditional bone preparation after the alignment guide 850 is removed.

Referring to FIG. 14A, a patient-specific posterior guide 900 for theolecranon fossa 86 of the distal humerus 72 is illustrated. Thepatient-specific guide 900 includes a three-dimensional engagementsurface 902, custom-made by computer imaging to conform to acorresponding portion of a patient's olecranon fossa 86 (see FIG. 1B).The posterior guide 900 is designed to reference an axis of rotation Dand an intramedullary axis D′. The posterior guide can include aplurality of elongated saw blade slots 904 for resecting the trochlea(see FIG. 1A) in preparation for a humeral implant. The guide 900 can besecured to the bone with one or more pins.

Referring to FIG. 14B, a modular posterior guide 930 for the olecranonfossa 86 of the distal humerus 72 is illustrated. The modular posteriorguide 900 is designed to reference an axis of rotation D and anintramedullary axis D′. The modular posterior guide 930 includes apatient specific cutting guide 910 removable coupled to a guidingcomponent 920. The patient specific cutting guide 910 includes athree-dimensional engagement surface 912, custom-made by computerimaging to conform to a corresponding portion of a patient's olecranonfossa 86 (see FIG. 1B). The cutting guide 910 can include a plurality ofelongated saw blade slots 914 for resecting the trochlea (see FIG. 1A)in preparation for a humeral implant. The cutting guide 910 is coupledto the guiding component 920 which is supported on the distal humeruswith a rod or pin 922 along the intramedullary axis D′. Because of thepatient-specific nature of the engagement surface 912, the cutting guide910 can fit in a unique position/orientation over the olecranon fossa 86and automatically align the rod 922 along the anatomic axis D′.

Referring to FIG. 15, a patient-specific alignment guide 950 isillustrated. The patient-specific alignment guide 950 is specific to thecapitellum 78 of the distal humerus 72 of the patient and includes athree-dimensional engagement surface 952, custom-made by computerimaging to conform to a patient's capitellum 78 (or portion thereof).The alignment guide 950 can include a guiding feature 954 including anelongated guiding bore 956 for an alignment pin 220 (similar to the pinshown in FIG. 12), computer modeled to be aligned with an anatomic axisE of the elbow joint, such as an axis center on and perpendicular to thesurface of the capitellum. The alignment pin 220 can be used toreference the anatomic axis E for additional bone preparation after thealignment guide 950 is removed.

The various patient-specific alignment guides can be made of anybiocompatible material, including, polymer, ceramic, metal orcombinations thereof. The patient-specific alignment guides can bedisposable and can be combined or used with reusable nonpatient-specific cutting and guiding components.

The foregoing discussion discloses and describes merely exemplaryarrangements of the present teachings. Furthermore, the mixing andmatching of features, elements and/or functions between variousembodiments is expressly contemplated herein, so that one of ordinaryskill in the art would appreciate from this disclosure that features,elements and/or functions of one embodiment may be incorporated intoanother embodiment as appropriate, unless described otherwise above.Moreover, many modifications may be made to adapt a particular situationor material to the present teachings without departing from theessential scope thereof. One skilled in the art will readily recognizefrom such discussion, and from the accompanying drawings and claims,that various changes, modifications and variations can be made thereinwithout departing from the spirit and scope of the present teachings asdefined in the following claims.

What is claimed is:
 1. A medical device for an elbow joint comprising: apatient-specific alignment guide including a three-dimensionalengagement surface customized in a pre-operating planning stage bycomputer imaging to closely mate and conform to a corresponding boneportion of a patient's elbow joint, the patient-specific-alignment guidedefining a guiding bore for guiding a pin along a reference axis,wherein the reference axis is an anatomic axis of rotation of the elbowjoint, the patient-specific alignment guide defining a guiding surfacefor guiding a blade for a bone-cut along a patient-specific resectionplane, wherein the guiding bore and guiding surface are customized forthe patient during a preoperative planning stage.
 2. The medical deviceof claim 1, wherein the guiding surface is an exterior planar surface ofpatient-specific alignment guide.
 3. The medical device of claim 1,wherein the guiding surface is a planar surface defined by an elongatedthrough slot defined in the patient specific alignment guide.
 4. Themedical device of claim 1, wherein the guiding surface comprises threeslots defined in the patient-specific alignment guide corresponding tothree resection cuts of a distal humerus.
 5. The medical device of claim4, wherein the three slots defined in the patient-specific alignmentguide correspond to distal, anterior, and posterior humeral cuts.
 6. Themedical device of claim 1, wherein the guiding surface comprises atleast one slot defined in the patient-specific alignment guide, the slotconfigured for a corresponding resection cut of a distal humerus.
 7. Themedical device of claim 1, wherein the engagement surface is customizedand configured for a corresponding lateral surface of a distal humerus.8. The medical device of claim 7, wherein the three-dimensionalengagement surface is shaped to conform to a lateral capitellum surfaceof the distal humerus of the elbow joint.
 9. The medical device of claim1, wherein the guiding bore is configured to be aligned with amedial/lateral anatomic axis of the elbow joint.
 10. The medical deviceof claim 1, wherein the three-dimensional engagement surface is made toclosely conform as a mirror image or negative to the corresponding boneportion of the patient's elbow joint.
 11. The medical device of claim 1,wherein the guiding bore is formed by a tubular guiding feature definingthe guiding bore.
 12. A medical device for an elbow joint, comprising: apatient-specific alignment guide including a three-dimensionalengagement surface customized in a pre-operating planning stage bycomputer imaging to be a negative of a corresponding bone portion of apatient's elbow joint, the patient-specific alignment guide having atubular guiding feature defining a guiding bore for guiding a pin alongan anatomic axis, the patient-specific alignment guide defining aplurality of guiding slots configured for guiding a blade for aplurality of bone cuts, wherein the guiding bore and the guiding slotsare customized for the patient during a pre-operative planning stage.13. The medical device of claim 12, wherein the plurality of guidingslots includes three slots defined in the patient-specific alignmentguide corresponding to distal, anterior, and posterior humeral cuts. 14.The medical device of claim 13, wherein the anatomic axis is an axis ofrotation of the elbow joint.
 15. The medical device of claim 14, whereinthe engagement surface is customized and configured for a correspondinglateral surface of a distal humerus.
 16. The medical device of claim 15,wherein the three-dimensional engagement surface is shaped to conform toa lateral capitellum surface of the distal humerus of the elbow joint.17. A method to resect a distal humerus of an elbow joint, comprising:positioning a patient-specific alignment guide having athree-dimensional engagement surface against a lateral surface of adistal humerus such that the engagement surface closely mates andconforms to the lateral surface of the distal humerus; passing a pinthrough a guide bore defined by the patient-specific alignment guide,wherein passing the pin through the guide bore further includes passingthe pin through the guide bore aligned along an anatomic axis ofrotation of the elbow joint; and guiding a blade through apatient-specific guide slot defined by the patient-specific alignmentguide to cut a portion of the distal humerus.
 18. The method of claim17, wherein guiding a blade further includes guiding a blade along afirst guide slot to form a distal humeral cut, a second guide slot toform an anterior humeral cut, and a third guide slot to form a posteriorhumeral cut.